Medication delivery device

ABSTRACT

An ear medication delivery device for delivering a treatment liquid and retaining the treatment liquid within an ear canal of a patient including a unitary, one piece earplug formed of a soft resilient material including an ear canal engaging portion and an external portion and defining a single internal passage therethrough. The external portion includes a major disk and an annular medication applicator receiving portion in fluid communication with the internal passage. The ear canal engaging portion includes at least two minor disks of progressively different size extending outwardly in a generally radial direction. The ear canal engaging portion defines a molded resilient valve unitary with the earplug that is shiftable from a closed position to an open position in either direction under a preselected fluid pressure and that resiliently returns to the closed position below the preselected fluid pressure.

This application is a continuation-in-part of application Ser. No.11/246,535 filed Oct. 7, 2006 entitled “Medication Delivery Device”.

FIELD OF THE INVENTION

The present invention is directed to devices and methods for treatingmaladies, particularly of the external ear canal, middle ear and eardrumand more particularly to such devices and methods that supply treatmentfluids to the external ear canal and into the middle ear through theeardrum where a tympanostomy tube or a perforation is present.

BACKGROUND OF THE INVENTION

There are many medical conditions related to the middle ear and externalear canal that affect a large patient population. Among these conditionsare otalgia (ear pain), otitis media (bacterial or viral infection ofthe middle ear), otitis externa (commonly known as swimmer's ear; aninfection of the outer ear that causes inflammation), post tympanostomytube otorrhea (“PTTO”) (drainage from middle ear after tube placement),otorrhea with tympanic membrane perforation (drainage from middle eardrum rupture that can be a complication of a middle ear infection) andcerumen otic impaction (ear wax debris). Many of these conditions arecommon and, from a medical perspective, are prioritized roughly aslisted.

The skin on the outer part of the external ear canal has special glandsthat produce cerumen, commonly called earwax (shown in the Figureslabeled 6). Cerumen traps particles of dust and dirt and repels waterthus helping to protect the delicate eardrum (shown in the Figureslabeled 8) from damage. The earwax, and any trapped dust or dirt, ismoved gradually out of the external ear canal by the lining of the earcanal. Eventually, the wax dries and falls out of the ear in smallflakes.

Normal cerumen production is good and healthy for the ear. But, cerumencan be produced in excess where it can block the ear canal. Also, normalproduction amounts of cerumen can be pushed into the external ear canalespecially while trying to remove the cerumen by cotton swabs, pencils,fingers and the like. Sometimes the attempt to remove cerumen pushes itfurther into the external ear canal where it contacts and is compressedagainst the eardrum 8. This condition, called cerumen impaction, canresult in temporary hearing loss that gradually worsens, earache,ringing in the ear (tinnitus) or a feeling of being stuffed or full. Theincidence of cerumen impactions varies as a function of age. In normalyoung adults the incidence is around 5%, while in the geriatricpopulation (>65 years) the incidence is as high as 34%.

Otitis media is an acute or chronic inflammation of the middle ear thatoften manifests itself as earache, fever, hearing loss, and sometimesrupture of the tympanic membrane. 62% of children will experience atleast one middle ear infection by age one and 83% will experience atleast one middle ear infection by age three. There are about 30-35million cases in the US per year of otitis media.

This condition alone accounts for 3% of all patient visits to hospitalsand physicians and is the most common specifically treated childhooddisease. The estimated cost of each episode of an ear infection is$90-$150 for an office visit and treatment and 1-2 days off for an adultparent care giver. In total, this translates into more than $1 billionannually in visits to the doctor in the US alone. The average total costof treatment of ear infections for children is $1,093. In total, thecost of surgical insertion of tympanostomy tubes in the US to treatotitis media is over $2 billion annually. Further, otitis media is the#1 reason for an antibiotic prescription in the US.

Otitis Externa is an inflammation of the external auditory canal. In1998, there were approximately 5,179,000 cases of otitis externadiagnosed in the United States. In the US, otitis externa occurs in 4out of every 1000 Americans every year.

Approximately 2 million tympanostomy tubes are placed in children in theUnited States each year. One common complication following the placementof tympanostomy tubes is the development of purulent ear drainage whichoften causes discomfort after tube placement. This condition is calledpost tympanostomy tube otorrhea (“PTTO”). Approximately 10 to 20% ofchildren will experience PTTO during the period immediately followingthe procedure to place the tube. The incidence of delayed PTTO isapproximately 30% while the tube is still in place. The incidence ofPTTO is even higher among infants and among young children who haverecurrent infections.

As can be seen, there are a large number of medical conditions affectingthe external ear canal, middle ear and eardrum and a large number ofpatients affected by these medical conditions. Consequently, there havebeen developed therapies and therapeutic devices to treat theseconditions especially by the application of medicaments to the affectedareas. For example, a common dropper is often used to deliver a solutionfor irrigation of the external ear canal or to deliver therapeuticsolutions to the external ear canal 26 or eardrum 8. One problem withsuch droppers is that the dropper must be loaded with the desired fluidprior to using the dropper. This is usually accomplished by depressing aflexible bulb on the end of the dropper and inserting the opposite endof the dropper in the desired solution. The flexible bulb is releasedcreating a vacuum that draws the fluid into the dropper. Thereafter,care must be taken to prevent the inadvertent discharge of the fluid.This process is cumbersome and messy and often results in spillage anddripping of the fluid.

Once the dropper has been loaded with fluid, the user inserts the end ofthe dropper in the patient's ear and squeezes the bulb to discharge anddeliver the fluid to the patient's ear canal. If the user squeezes thebulb too hard, a pressurized stream of fluid exits the dropper andcontacts the patient's ear, particularly the patient's eardrum 8, whichcan cause pain or discomfort.

The dropper is then removed from the patient's ear. Gravity holds thefluid in the patient's ear. Consequently, the patient must be on his orher side when the fluid is delivered so that the fluid will enter and beretained in their ear. Thereafter, if it is desired that the fluidcontinue to be retained in the patient's ear for therapeutic purposes,the patient must continue to be on his or her side or else the fluidwill drain from their ear. Requiring the patient to be on their side fordelivery of the fluid and to retain the fluid in the external ear canalis problematic especially for small, restless or ambulatory children oradults.

Further, once it is desired to remove the fluid from the ear, thepatient turns their head so that gravity can cause the fluid to drainfrom the ear canal. The fluid is then recovered and the patient cleanedup from the fluid, particularly from the drainage path of the fluid, bythe application of towels or cotton balls. This is also a messy processthat spreads the used fluid over portions of the patient or thepatient's clothes and surroundings. All these problems with droppers arein need of solutions.

Several devices have been developed to address some of these problems.For instance, U.S. Pat. No. 4,528,714 issued to Norbert Leopoldi andWilliam P. Heinrich on Mar. 31, 1981 entitled “Ear Syringe” discloses anear syringe having a bulb for containing fluid and a stem for enteringthe external ear canal to inject the fluid from the bulb into theexternal ear canal to flush out and remove foreign matter or cerumen.The '714 device has a built-in pressure regulator valve to control thedischarge velocity of the fluid exiting from the stem of the device.This minimizes the chance that a pressurized stream of fluid willcontact the eardrum 8 and build up fluid pressure in the external earcanal and subsequently on the eardrum 8 to cause discomfort or pain tothe patient while using the device. This device does not address theproblems of the mess associated with filling the device or administeringand removing the fluid to and from the ear canal. Further, this devicedoes not address the problem requiring the patient to be on his or herside for the delivery of fluid or having to retain this position to keepthe fluid in the ear canal.

Another device to treat maladies of the external ear canal, middle earand ear drum is disclosed in U.S. Pat. No. 5,674,196 issued to JohnDonaldson and Krista Donaldson on Oct. 7, 1997 entitled “Device forIntroducing Medical Fluid into the Human Ear.” This patent discloses adevice for administering medical fluid to the eardrum 8 or external earcanal 26. The '196 device includes an earplug that is inserted into theear canal. The earplug fits snugly in the external ear canal andsubstantially seals the ear canal. The earplug has a conduit passingthrough it to allow fluid from a syringe to be introduced to theexternal ear canal between the earplug and the eardrum 8. Once themedical fluid is introduced into the ear, the conduit can be sealed toretain the medical fluid in the ear canal. In this way, the medicalfluid comes into and remains in contact with the external ear canal 26or eardrum 8 or both so that the medical fluid can perform its intendedtherapeutic function.

But, this device does not address the problems associated with puttingfluid into the syringe. Further, this device does not address theproblem of eliminating the mess associated with removing the fluid fromthe patient's ear canal.

So, there exists a need for a device to deliver therapeutic fluids tothe external ear canal 26 or eardrum 8 has some or all of the followingcharacteristics: is easy to fill or pre-filled with treatment fluid (toeliminate the associated mess); allows the fluid to be delivered ineither a supine or upright position; allows the patient to be ambulatoryafter applying the fluid; seals the fluid in the ear canal; allows thefluid delivery bulb to be separated from the device in contact with thepatient's ear; and allows the used treatment fluid to be easily andcleanly removed from the patient's ear at the appropriate time.

SUMMARY OF THE INVENTION

The present invention is a device and method for treating maladies,particularly of the external ear canal, middle ear and eardrum. Thedevice in a preferred embodiment comprises an earplug and a deliverybulb, reservoir, syringe or ear dropper that holds treatment fluid(collectively “treatment fluid reservoir”). A lumen extends through theearplug and connects the treatment fluid reservoir to an orifice locatedat the distal end of the earplug. A one-way valve is located along thelumen to allow treatment fluid to only flow from the treatment fluidreservoir to the orifice and not vice versa. The earplug forms a sealwith the patient's external ear canal and, combined with the one-wayvalve, retains treatment fluid in the patient's external ear canal whereit can perform its therapeutic function. In one embodiment, theinvention includes a collection bag connected through the earplug to anorifice near the distal end of the earplug to collected waste treatmentfluid.

A therapeutic method comprises using a device, as disclosed herein, todeliver treatment fluids to the patient's external ear canal forirrigation, for the therapeutic benefit of the treatment fluids for theshort term, for longer term therapeutic benefit by delivering andretaining the treatment fluid in contact with the patient's external earcanal or eardrum for a desired time period to provide a therapeuticbenefit or to deliver treatment fluid to a patient's external ear canalwhere it can pass into the patient's middle ear through a tympanostomytube placed in the patient's eardrum or ear through an eardrumperforation.

In a further embodiment, a treatment fluid delivery device is disclosedfor treating maladies of a patient's body orifice or body cavity that issubstantially as described in connection with the device for treatingmaladies of the external ear canal, middle ear and eardrum. In thisembodiment, the earplug is modified in size, shape and possibly otherphysical properties such as flexibility, rigidity and pliancy to becomea plug that accommodates forming a sealing fit with the orifice or bodycavity to which it is applied. The invention includes a correspondingmethod for treating maladies of a patient's body orifice or body cavitythat comprises using a device, as disclosed herein, to deliver treatmentfluids to the patient's body orifice or body cavity and retaining thetreatment fluid in contact with the patient's body orifice or bodycavity for a desired time period to provide a therapeutic benefit or todeliver treatment fluid to a patient's body orifice or body cavity.

It is therefore an object of the invention in one embodiment to providea device that delivers treatment fluids to the patient's external earcanal for irrigation.

It is therefore an object of the invention in one embodiment to providea device that delivers treatment fluids to the patient's external earcanal for the therapeutic benefit of the treatment fluids for the shortterm.

It is therefore an object of the invention in one embodiment to providea device that delivers treatment fluids to the patient's external earcanal for longer term therapeutic benefit by delivering and retainingthe treatment fluid in contact with the patient's external ear canal oreardrum for a desired time period to provide a therapeutic benefit.

It is therefore an object of the invention in one embodiment to providea device that delivers treatment fluids to the patient's external earcanal to deliver treatment fluid to a patient's external ear canal whereit can pass into the patient's middle ear through a tympanostomy tubeplaced in the patient's eardrum or through an eardrum perforation.

It is also an object of the invention in one embodiment to make an earsyringe that requires less effort than previous devices to directsolution into the ear because the mechanism for holding treatment fluidsis already filled with treatment fluid and is connected to the earplug.

It is also an object of the invention in one embodiment to make an earsyringe that is easier to use than previous devices since fewer stepsare needed to deliver the treatment fluids into the ear.

It is also an object of the invention in one embodiment to make an earsyringe that produces less mess in introducing solution into the earthan currently available devices since the mechanism for holdingtreatment fluid is already filled with treatment fluid and is connectedto the earplug.

It is also an object of the invention in one embodiment to make an earsyringe that does not allow the treatment fluid to be absorbed by thedevice as compared to a cotton ball.

It is also an object of the invention in one embodiment to make an earsyringe that may be applied to a patient who may be standing, sitting orin a prone position as compared to prior art devices where the patientneeds to remain laying down, particularly on his or her side, afterdelivery of treatment fluids.

It is also an object of the invention in one embodiment to make an earsyringe that, following the administration of the treatment fluid,allows the patient to move around and be ambulatory and does not have toremain motionless and on their side as compared with prior art devices.

It is therefore an object of the invention in one embodiment to providea device that delivers treatment fluids to the patient's body orifice orbody cavity.

It is therefore an object of the invention in one embodiment to providea device that delivers treatment fluids to the patient's body orifice orbody cavity for the therapeutic benefit of the treatment fluids for theshort term.

It is therefore an object of the invention in one embodiment to providea device that delivers treatment fluids to the patient's body orifice orbody cavity for longer term therapeutic benefit by delivering andretaining the treatment fluid in contact with the patient's body orificeor body cavity for a desired time period to provide a therapeuticbenefit.

It is therefore an object of the invention in one embodiment to providea device that delivers treatment fluids to the patient's body orifice orbody cavity that requires less effort or is easier to use thanpreviously known devices.

It is also an object of the invention in one embodiment to provide adevice that delivers treatment fluids to the patient's body orifice orbody cavity that may be applied to a patient who may be standing,sitting or in a prone position as compared to prior art devices wherethe patient needs to remain laying down, particularly on his or herside, after delivery of treatment fluids.

It is also an object of the invention in one embodiment to provide adevice that delivers treatment fluids to the patient's body orifice orbody cavity that, following the administration of the treatment fluid,allows the patient to move around and be ambulatory and does not have toremain motionless.

These and other objects of the invention will be clear from thedescription contained herein and particularly with reference to thefollowing Detailed Description of the Invention and the associatedDrawings.

In a further embodiment, a treatment fluid delivery device is disclosedfor treating maladies of the external ear canal, middle ear and eardrum.In this embodiment, the earplug is formed of a soft, resilient, moldedmaterial, a portion of which engages the ear canal. The internal earengaging portion presents three minor disks of progressively differentsizes on an external surface thereof. An internal lumen extends throughthe length of the treatment fluid delivery device. The external portionincludes a major disk and an annular medication applicator receivingportion in fluid communication with the internal lumen. The internallumen extends through the internal ear engaging portion and the externalportion.

The internal lumen of the treatment fluid delivery device is contoured,shaped and dimensioned to receive a portion of a medication applicatorsuch as an ear dropper, an eye dropper, a syringe, or similar device.The internal lumen of the treatment fluid delivery device and themedication applicator are dimensioned such that a liquid tight seal isformed between the two. A molded, resilient valve is contained in theear engaging portion and controls fluid flow through a segment of theinternal lumen and is integrally formed of the same material as thetreatment fluid delivery device by, for example, injection molding. Thevalve opens in either direction under a preselected fluid pressure andcloses below the preselected fluid pressure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an embodiment of the present invention.

FIG. 2 is a side cross-sectional view of the embodiment of FIG. 1.

FIG. 3 is a side cross-sectional view and an alternate embodiment of thepresent invention.

FIG. 4 is a side cross-sectional view of an alternate embodiment of FIG.1.

FIG. 5 is a side cross-sectional view of an alternate embodiment of thepresent invention.

FIG. 6 is a side cross-sectional view of an alternate embodiment of theattachment mechanism of the present invention.

FIG. 8 is a cross-sectional view of the embodiment of FIG. 1 in use in apatient's ear.

FIG. 9 is a cross-sectional view of the embodiment of FIG. 1 in use in apatient's ear with the bulb separated from the stem.

FIG. 10 is a side cross-sectional view of an alternate embodiment of thepresent invention with a waste collection bag.

FIG. 11 is a cross-sectional view of the earplug of the embodiments ofFIGS. 10 and 13 showing the placement of the lumen and collection tube.

FIG. 12 is a cross-sectional view of an alternate embodiment of theearplug of the embodiments of FIGS. 10 and 13 showing an alternateplacement of the lumen and collection tube.

FIG. 13 is a side cross-sectional view of an alternate embodiment of theinvention of FIG. 10.

FIG. 14 is a side cross-sectional view of the embodiment of FIG. 10 inuse in a patient's ear.

FIG. 15 is a side cross-sectional view of an alternate embodiment of theinvention of FIG. 1.

FIG. 16 is a side cross-sectional view of an alternate embodiment of theinvention of FIG. 15.

FIG. 17 is a side cross-sectional view of an alternate embodiment of theinvention.

FIG. 18 is a side cross-sectional view of another alternate embodimentof the invention.

FIG. 19 is a schematic diagram of an alternate embodiment of theinvention.

FIG. 20 is a schematic diagram of a variant of the embodiment of FIG.19.

FIG. 21 is a perspective view of the treatment fluid delivery deviceaccording to an example embodiment of the invention.

FIG. 22 is a cross-sectional view of the embodiment of FIG. 21.

FIG. 23 is a sectional view of the closed valve of the embodiment ofFIG. 21.

FIG. 24 is a sectional view of the open valve of the embodiment of FIG.21.

FIG. 25 is a cross-sectional view of the alternate embodiment of FIG. 21positioned in a patient's ear.

FIG. 26 is a cross-sectional view of the alternate embodiment of FIG. 21positioned in a patient's ear with a medication applicator inserted.

FIG. 27 is a cross-sectional view of the alternate embodiment of FIG. 21positioned in a patient's ear with treatment fluid being delivered viaan inserted medication applicator.

DETAILED DESCRIPTION

Throughout the description, like members, elements or parts, whereverreferenced or described are referred to by like reference numbers.Unless otherwise described, the description and functioning of anelement set out in one portion of the application applies to the elementreferred to by the same reference number in another portion of thedescription. Further, the present description includes description ofseveral embodiments of the invention. Again, reference to or descriptionof an element in connection with one embodiment refers to the physicalattributes, characteristics or function of an element wherever set forthin the description.

The present invention is an ear medication delivery device, shown in theFigures generally labeled 10, and an associated therapeutic method oftreating ailments of the external ear canal, middle ear and eardrum 8.The purpose of the device is to provide medicament such as antibiotics,antifungals, steroids and analgesics such as are commonly used forswimmers ear and other ear infections and cleansing fluid or irrigationfluid, collectively treatment fluid 12, to a patient's external earcanal 26, eardrum 8, middle ear or all of the above and in oneembodiment, retain the treatment fluid 12 in the patient's external earcanal 26 in contact with the ear canal, middle ear and/or eardrum 8.

The device 10 is comprised of an earplug 14 and a delivery bulb 16.Earplug 14 has a distal end 18, a proximal end 20, an outer body 22 anda lumen 24. The function of outer body 22 is to contact and provide aseal with the patient's external ear canal 26. Consequently, outer body22 is preferably relatively frustoconical in shape, made of a somewhatpliable hypoallergenic material that is non-reactive with the tissue ofthe external ear canal like compressible resilient elastomeric foam,rubber, silicone, silicone putties, vinyl or acrylics and dimensioned sothat the distal end 18 of the earplug 14 may be placed into the externalear canal 26 but that the portions of the outer body 22 nearer theproximal end 20 of the earplug 14 will come into sealing contact withthe patient's external ear canal 26. Because body 22 is somewhatpliable, it will conform to the shape of the patient's external earcanal 26 as the earplug 14 is placed in the patient's external ear canal26 as will be explained hereafter. Since ear canals become larger withage, it may be desirable to produce the device 10 with several sizes forthe outer body 22 in order to have an optimal sealing fit in thepatient's external ear canal 26.

Although outer body 22 has been described as being preferably relativelyfrustoconical in shape, outer body 22 can take on any shape so long asouter body 22 is able to perform the function of contacting andproviding a seal with the patient's external ear canal 26. Withoutlimiting the possible shapes for outer body 22, outer body 22 could alsobe relatively cylindrical, conical, prismatic, prolate spheroidal orpyramidal. Further, outer body 22, in whatever form it takes, could havesmooth sides, ridges or undulations. Further, outer body 22 in whateverform it takes could have variable flexibility, rigidity and pliancydepending on the treating or recommending physician's preferenceconsidering the patient's age and anatomy, the disease or malady, theprogression or state of the disease or malady or other conditions orfactors that, based on the physician's judgment, would affect such achoice of material and properties.

As stated above, earplug 14 has a lumen 24. Lumen 24 runs essentiallyentirely through earplug 14 and has a distal end 28 and a proximal end30. In the embodiment of FIGS. 1 and 2, lumen 24 is formed by removingthe material of outer body 22 or by molding the earplug 14 so that alumen 24 is formed. In another embodiment, shown in FIG. 3, lumen 24 isformed in a separate tube 32 that is placed within earplug 14 where thetube 32 has a hollow lumen 24 extending along the entire length of tube32. Tube 32 may be made of the same or different material than earplug14.

The length of lumen 24, whether alone or in the embodiment with tube 32,will vary with the size of the earplug 14. But, it is preferred, but notnecessary, that the earplug 14 be relatively short, and consequentlythat the lumen 24 will be relatively short, so that the entire device 10is compact and easy to be held in a user's hand (FIGS. 1-4).

Lumen 24 extends from the delivery bulb 16 to the distal end 18 of theearplug 14 where the lumen 24 terminates in an orifice 34. Lumen 24 actsas the channel for treatment fluid 12 to move from the delivery bulb 16to and out of the orifice 34. In the preferred embodiment of theinvention, orifice 34 is located at the ultimate distal end 18 ofearplug 14. But, as shown in FIG. 4, orifice 34 may be located along thesurface of the outer body 22 away from the ultimate distal end 18 ofearplug 14 but still before the part of outer body 22 that contacts andprovides a seal with the patient's external ear canal 26. This offsetconfiguration will result in the treatment fluid 12 leaving the orifice34 and contacting the wall of the external ear canal near the orificeinstead of leaving the orifice 34 with the possibility of directlycontacting the user's eardrum 8. This offset configuration for thelocation of the orifice 34 may be particularly desirable where theuser's eardrum 8 is inflamed or otherwise sensitive to contact by apressurized stream of treatment fluid 12. In a further variant, severalorifices 34 may be formed including combinations of an orifice 34located at the ultimate distal end 18 of the earplug 14 and one or moreorifices 34 located at offset locations located along the surface of theouter body 22 away from the ultimate distal end 18 of earplug 14 asdescribed above or several orifices 34 located along the surface of theouter body 22 away from the ultimate distal end 18 of earplug 14 asdescribed above but without an orifice 34 located at the ultimate distalend 18 of the earplug 14.

Earplug 14, in the embodiment shown in FIG. 2, is made in one piece ofsomewhat pliable hypoallergenic material that is non-reactive with thetissue of the external ear canal like compressible resilient elastomericfoam, rubber, silicone, silicone putties, vinyl or acrylics bytechniques such as molding and machining. However, as mentioned, earplug14 may also be made of separate pieces combined together to make theearplug 14. For example, as shown in FIG. 3, the tube 32 and outer body22 of earplug 14 are made separately, either of the same or differentmaterials. The outer body 22 is then attached, by means well understoodin the art, including but not limited to gluing, frictional fit,mechanical connection or threaded connection, to the outer surface 36 ofthe tube 32 so that the distal end 28 of the tube 32 is aligned with theorifice 34 of the earplug 14.

As mentioned, in this embodiment tube 32 and outer body 22 could be madeof different material. For example, tube 32 could be made of arelatively rigid material such as is common for cannulae used formedical uses to provide a solid base for the device 10. Examples of suchmaterial includes, but is not limited to, silicone, polyvinylchloride(PVC), polyurethane, polyether urethane, polyether urethane urea,polyamide, polyacetal, polyester, poly ethylene-chlorotrifluoroethylene,poly tetrafluoroethylene (PTFE or “Teflon®”), styrene butadiene rubber,polyethylene, polypropylene, polyphenylene oxide-polystyrene,poly-a-chloro-p-xylene, polymethylpentene, polysulfone and other relatedbiostable polymers. In this embodiment as well, outer body 22 is made ofa somewhat pliable hypoallergenic material that is non-reactive with thetissue of the external ear canal like compressible resilient elastomericfoam, rubber, silicone, silicone putties, vinyl or acrylics bytechniques such as molding and machining to allow it to be deformed intoa sealing fit in the patient's external ear canal 26.

In an embodiment shown in FIG. 5, earplug 14 is of a size to fit in thepatient's external ear canal 26. But, tube 32 is quite long and flexibleand extends beyond earplug 14 to essentially act as a conduit connectingthe delivery bulb 16, which may be located a distance away from theearplug 14, to the earplug 14. Tube 32 in this embodiment may alsoinclude a pinch valve 60 located along tube 32 preferably near thedistal end 28 of tube 32. The function of pinch valve 60 is to open orclose the tube 32 to the passage of treatment fluid 12. Consequently,pinch valve 60 may take any of a number of forms well-known in the art.Pinch valve 60 is opened when it is desired for treatment fluid 12 topass from the delivery bulb 16 to the earplug 14 but may be closed whentube 32 is separated from the earplug 14, as described hereafter, toprevent spillage of treatment fluid 12 from the tube 32.

As mentioned above, the device 10 includes a delivery bulb 16. Thefunction of delivery bulb 16 is to store treatment fluid 12 and deliverthe treatment fluid 12 to the earplug 14 at the appropriate time. In thepreferred embodiment, delivery bulb 16 is generally typical of syringebulbs used to irrigate the external ear canal and has a distal end 38and a proximal end 40. Consequently, the delivery bulb 16 is preferablymade of a flexible material such as vinyl or a rubber compound thatallows the delivery bulb 16 to expand when fluid is placed into or drawninto the delivery bulb 16 and allows the delivery bulb 16 to be squeezedor compresses to expel the treatment fluid 12 from the delivery bulb 16to and out of the earplug 14. Preferably, the material and thickness ofdelivery bulb 16 is such that when delivery bulb 16 is squeezed and thenreleased, delivery bulb 16 on its own will return to its un-squeezed orun-compressed condition.

In a variant of this embodiment, delivery bulb 16 is made of a materialor of a thickness of material that allows the delivery bulb 16 to expandwhen fluid is placed into or drawn into the delivery bulb 16 and allowsthe delivery bulb 16 to be squeezed or compresses to expel the treatmentfluid 12 from the delivery bulb 16 to and out of the earplug 14 but thatdoes not allow the delivery bulb 16, when squeezed and then released, toreturn to its un-squeezed or un-compressed condition. In this variant,the material of delivery bulb 16 could include, but not be limited toflexible rubber, soft thermoplastic material such as vinyl or a siliconelastomer or the thickness of the material of delivery bulb 16 could bereduced to make the delivery bulb 16 more pliant.

The delivery bulb 16 is preferably generally spherical and may, but isnot required to have a flat spot or concavity 42 on the proximal end 40of the delivery bulb 16 that provides an area for standing the deliverybulb 16 upright when it is disconnected from the earplug 14 as will bedescribed hereafter. Although the preferred shape of the delivery bulb16 is roughly spherical it is not required to be spherical. Other shapesmay be used, including the lack of any predefined shape, so long as thedelivery bulb 16 performs the functions described above. One of analmost limitless number of examples for shapes of the delivery bulb 16is shown in FIG. 5 in connection with an alternate embodiment of thedevice 10. As shown in this example, the delivery bulb 16 has the shapeof an elongated bladder. In a further variant of the delivery bulb 16,delivery bulb 16 could be a bellows that allows the delivery bulb 16 toexpand as treatment fluid 12 is drawn in to the delivery bulb 16 andcollapse as the treatment fluid 12 is expelled from the delivery bulb16.

Earplug 14 also preferably includes an attachment mechanism 44 locatedat the proximal end 20 of earplug 14. The function of attachmentmechanism 44 is to sealingly connect the delivery bulb 16 to the earplug14. In the case of one set of embodiments, the attachment mechanism 44connects the earplug 14 to the proximal end 30 of tube 32. In oneembodiment, as shown in FIG. 2, attachment mechanism 44 is a channel 46formed at the proximal end 34 of earplug 14. Delivery bulb 16 has asleeve 48 made of the extension of the material of delivery bulb 46 thatfits into and around channel 46 to sealingly connect delivery bulb 16 toearplug 14 so that channel 46 and sleeve 48 interact in a male-femalerelationship, respectively. In a variant of this embodiment, shown inFIG. 6, delivery bulb 16 has a channel 50 formed at its distal end 38and earplug 14 has a sleeve 52, made of the extension of the material ofthe earplug 12, that interact in a female-male relationship,respectively.

In the embodiment of FIG. 5, the delivery bulb 16 is located a distanceaway from the earplug 14. Tube 32 connects the delivery bulb 16 to theearplug 14 and forms the lumen 24 that allows treatment fluid 12 in thedelivery bulb 16 to pass to and out of the earplug 14 through theorifice 34. As a result, in this embodiment, tube 32 extend from thedistal end 18 of the earplug 14 to and out of the proximal end 20 ofearplug 14 to the delivery bulb 16 where tube 32 is fluidly connected toallow treatment fluid 12 to flow from the delivery bulb 16 through thelumen 24 of the tube 32 to exit the tube 32 at the orifice 34. In thisembodiment, because the tube 32 extends from the distal end 18 of theearplug 14 to and out of the proximal end 20 of the earplug 14, there isno need for an attachment mechanism 44 at the proximal end 20 of theearplug 14.

However, there is a need connect the proximal end 30 of the tube 32 tothe delivery bulb 16. In this embodiment, the device 10 includes adelivery bulb attachment mechanism 54 that connects the proximal end 30of the tube 32 to the delivery bulb 16. In the form shown in FIG. 5,delivery bulb attachment mechanism 54 is a channel 56 formed at theproximal end 30 of tube 32 and a sleeve 58 formed in the distal end 38of delivery bulb 16 so that channel 56 and sleeve 58 interact in amale-female relationship, respectively. Alternately, delivery bulbattachment mechanism 54 could be a channel formed at the distal end 38of delivery bulb 16 and a sleeve formed in the proximal end 40 of tube32 so that the channel and sleeve interact in a female-malerelationship, respectively.

Further, tube 32 could be integrally formed with the distal end 38 ofdelivery bulb 16 so that there is no need to have a delivery bulbattachment mechanism 54. In this variant, the tube 32 extends from thedelivery bulb 16 to the earplug 14 where the distal end 28 of tube 32may be connected to the proximal end 20 of the earplug 14 through theattachment mechanism 44 described above. This embodiment as well mayinclude a connection between the tube 32 extending from the deliverybulb 16 to the proximal end 20 of the earplug 14 to the tube 32 locatedwithin the earplug 14 (in the embodiments having such a tube 32 in theearplug 14) or may be connected directly to the lumen 24 at the proximalend 20 of the earplug 14 (in those embodiments where lumen 24 is formeddirectly in the earplug 14).

Specific examples have been given for the structure of attachmentmechanism 44 and delivery bulb attachment mechanism 54. However, thespecific structure of these connections is not critical to theinvention. It is clear that it is well understood in the art how toconnect tubing together or to connect tubing to bags or implements.Consequently, it is intended that any well understood mechanism thatperforms the function of either attachment mechanism 44 or delivery bulbattachment mechanism 54 is within the scope of the invention.

Earplug 14 also includes a one-way valve 64. The function of the one-wayvalve 64 is to prevent the treatment fluid 12 from re-entering thedelivery bulb 16 once the treatment fluid 12 has left the delivery bulb16. In particular, this allows the treatment fluid 12 to remain in theexternal ear canal 26 for a desired period of time without exiting thedevice 10 through the proximal end 20 of the lumen 24. Further, thisallows the delivery bulb 16 to be removed from the earplug 14 when theearplug 14 is in position in a patient's external ear canal 26. Thisallows the earplug 14 to retain the treatment fluid 12 in the patient'sexternal ear canal 26 while minimizing the inconvenience of having thedelivery bulb 16, with its accompanying bulk, attached to the earplug 14while the treatment fluid 12 is retained in the patient's external earcanal performing its therapeutic purposes.

The one-way valve 64 is preferably, but not limited to being, locatedclose to the delivery bulb 16 so that when delivery bulb 16 is separatedfrom the earplug 14 after the treatment fluid 12 has been expelled fromthe delivery bulb 16, virtually no treatment fluid 12 remains proximalto the one-way valve 64 to spill when the delivery bulb 16 is removed.Although the one-way valve 64 is preferably located-close to thedelivery bulb 16, it is not required to be so placed. The one-way valve64 may be located anywhere along the lumen 24 in whatever form lumen 24takes. Further, more than one one-way valve 64 may be located along thelumen 24.

As stated, the function of one-way valve 64 is to prevent the treatmentfluid 12 from re-entering the delivery bulb 16 once the treatment fluid12 has left the delivery bulb 16. The present invention intends that anyvalve that performs this function may be used as the one-way valve 64.However, without excluding any possible valves that meet this functionalcriteria, the following valve types may be used as the one-way valve 64:slit valves, check valves including swing valves (monocuspid, bicuspid,tricuspid), lift valves, ball valves, tilting disk valves, dual plate(leaflet) valves, diaphragm valves, flap valves and general valvesincluding ball valves, butterfly valves, check valves, diaphragm valves,gate valves, globe valves, plug valves, duck bill valves and pinchvalves. In this way, one-way valve 64 allows treatment fluid 12contained within the delivery bulb 16 to be dispensed by squeezing thedelivery bulb 16, sending the treatment fluid 12 past the one-way valve64, through the lumen 24 contained within the earplug 14 and out of theorifice 34. The one-way valve 64 may be composed of various materials.Examples of such material includes, but is not limited to, silicone,polyvinylchloride (PVC), polyurethane, polyether urethane, polyetherurethane urea, polyamide, polyacetal, polyester, polyethylene-chlorotrifluoroethylene, poly tetrafluoroethylene (PTFE or“Teflon®”), styrene butadiene rubber, polyethylene, polypropylene,polyphenylene oxide-polystyrene, poly-a-chloro-p-xylene,polymethylpentene, polysulfone and other related biostable polymers. Infact, one-way valve 64 may be made of the same material as the earplug14 and may additionally be molded with the earplug 14 as the earplug 14is molded.

As mentioned above, more than one one-way valve 64 may be located alongthe lumen 24. In this configuration of multiple one-way valves 64, theone-way valves 64 may be of the same type or of different types.Further, the one-way valves 64 may be of different sizes, shapes, flowrates, opening pressures or other physical or functional properties.

In use, the delivery bulb 16 is first filled with treatment fluid 12.This may be accomplished in many ways. The delivery bulb 16 could bepre-filled with a desired treatment fluid 12 and then attached to theearplug 14 as described above. Or, the delivery bulb 16 could beseparated from the earplug 14, turned so that the open distal end 38 ofthe delivery bulb 16 is facing upwards, and treatment fluid 12 pouredfrom a container or injected from a syringe, dropper or spigot into thedelivery bulb 16 through the open distal end 38. Other ways of fillingthe delivery bulb 16 with treatment fluid 12 may occur to those skilledin that art and are intended to be included in the use of the device 10.

With treatment fluid 12 in the delivery bulb 16, the distal end 18 ofthe earplug 14 is inserted into the patient's external ear canal 26 asshown in FIG. 8. Treatment fluid 12 contained within the delivery bulb16 is dispensed by squeezing the delivery bulb 16 thereby releasing thetreatment fluid 12 through the lumen 24 and orifice 34 into the externalear canal 26. Once the treatment fluid 12 is dispensed into the externalear canal 26, the empty delivery bulb 16 may be separated from andremoved from the earplug 14 by separating the channel 46 from the sleeve48 (FIG. 9) or the channel 50 from the sleeve 52 or by whateverappropriate means the attachment mechanism 44 provides, as is wellunderstood in the art.

The inserted earplug 14 with its one-way valve 64 prevents the treatmentfluid 12 or cleansing solution from draining out of the external earcanal 26, thus allowing the entrapped treatment fluid 12 to remain inthe external ear canal 26 for a desired period of time. The earplug 14is then removed from the external ear canal 26 allowing the resultingmixture of treatment fluid 12 and wax debris or waste fluid 28 to drainout of the ear by gravity.

In embodiments of the device 10 represented in FIGS. 10-13, the device10 includes a collection tube 66 and a collection reservoir 68.Collection tube 66 is a hollow tube preferably located in earplug 14that extends from a collection orifice 70 to the collection reservoir68. Collection orifice 70 is preferably, but not required to be, locatednear the distal end 18 of earplug 14. Alternately, collection tube 66can be located in whole or in part on the outside of the outer surface22 of the earplug 14.

The function of collection reservoir 68 is to collect waste treatmentfluid 72. Waste treatment fluid 72 is treatment fluid 12 that hasalready been injected into the patient's external ear canal 26 and whichmay also include earwax or other debris from the patient's external earcanal 26. Because the function of collection reservoir 68 is to collectwaste treatment fluid 72, collection reservoir 68 need only be able toreceive and contain the waste treatment fluid 72. Consequently, in thepreferred embodiment the collection reservoir 68 is a flexible bag suchas a bag made of flexible rubber, soft thermoplastic material such asvinyl or a silicon elastomer. Alternately, collection reservoir 68 couldbe made of a somewhat more rigid material such as polyester but of areduced thickness or of a bellows configuration. In either of these forma, the collection reservoir 68, when empty, is collapsed and when full,expands to hold the waste treatment fluid 72.

In the embodiment, shown in FIG. 10, the collection reservoir 68 isdirectly attached to the earplug 14 and collection tube 66 fluidlyconnects the collection reservoir 68 to the collection orifice 70. Inthis embodiment, the collection tube 66 terminates in a collectionreservoir connection fitting 78. The function of collection reservoirconnection fitting 78 is to fluidly connect the collection reservoir 68to the earplug 14 through the collection tube 66.

Once again, it is well known how to connect tubing such as thecollection tube 66 to a reservoir such as the collection reservoir 68.Consequently, there is an almost limitless number of ways to accomplishthis connection. One configuration of collection reservoir connectionfitting 78 is for earplug 14 to include a collection reservoirattachment lip 80 located near the proximal end 20 of earplug 14. In thepreferred embodiment, collection reservoir attachment lip 80 is a branchformed near the proximal end 20 of earplug 14 that extends away fromearplug 14 at an angle. Collection reservoir 68 has a sleeve 82 mode ofan extension of the material of collection reservoir 68 that fits intoand around connection reservoir attachment lip 80 to sealingly connectcollection reservoir 68 to collection tube 66 and hence to earplug 14.In these embodiments with the collection reservoir 68, the earplug 14has both a lumen 24 and a collection tube 66. There are many well knownways to have dual lumens in devices. One such way is shown in FIG. 11where the lumen 24 and the collection tube 66 lie within the earplug 14in a side-by-side configuration. Another way to have lumen 24 andcollection tube 66 in the earplug is shown in FIG. 12 where thecollection tube 66 partially surrounds the lumen 24 (or vice versa).

In an alternate embodiment, shown in FIG. 13, the collection reservoir68 is located remote from the earplug 14. In this embodiment, thecollection reservoir 68 is also attached to the collection orifice 70 ofearplug 14 through the collection tube 66. But, a hollow conduit 84connects the collection tube 66 to the collection reservoir 68 so thatwaste treatment fluid 72 may be collected from the area distal to thedistal end 18 of the earplug 14 through the collection orifice 70 andpassed through the collection tube 66 and hollow conduit 84 to thecollection reservoir 68.

Collection tube 66 in this embodiment may also include a pinch valve 86located along collection tube 66 preferably near the end of thecollection tube 66 near earplug 14. The function of pinch valve 86 is toopen or close the collection tube 66 to the passage of waste treatmentfluid 72. Consequently, pinch valve 86 may take any of a number of formswell-known in the art. Pinch valve 86 is opened when it is desired forwaste treatment fluid 72 to pass from the earplug 14 to the collectionreservoir 68 but may be closed when collection tube 66 is separated fromthe earplug 14, as for example, at the end of the therapeutic session,to prevent spillage of waste treatment fluid 72 from the collection tube66.

In the embodiments of device 10 having a collection reservoir 68,collection reservoir 68 may aid in the retrieval of waste treatmentfluid 72. This is preferably accomplished by collection reservoir 68providing a slight vacuum to pull the waste treatment fluid 72 into thecollection orifice 70, through the collection tube 66 (and through thehollow conduit 84, if present) into the collection reservoir 68. In thisembodiment, instead of collection reservoir 68 being made of a flexiblematerial, collection reservoir 68 is made of a material such as vinyl ora rubber compound that allows the collection reservoir 68 to expand asfluid is placed into or drawn into the collection reservoir 68.Preferably, the material and thickness of collection reservoir 68 issuch that when collection reservoir 68 is squeezed and then released,collection reservoir 68 on its own will return to its un-squeezed orun-compressed condition and in the process of doing so, draw a vacuumthat helps to draw the waste treatment fluid 72 into the collectionreservoir 68.

In these embodiments having a collection reservoir 68 as well, as shownin FIG. 14, the earplug 14 is placed in the patient's external ear canal26 and treatment fluid 12 is dispensed from the delivery bulb 16 intothe external ear canal 26 through lumen 24 in earplug 14. The resultingmixture of treatment fluid 12 and earwax debris or waste treatment fluid12 drains out of the external ear canal 26 through the collection tube66 contained within the earplug 14 and into the collection reservoir 68connected to the earplug 14. The collection reservoir 68 containing thewaste treatment fluid 72 may then be discarded.

In use, the delivery bulb 16 may be preloaded with treatment fluid 12and attached to the earplug 14 as described above. Alternately, as shownin FIG. 15, the delivery bulb 16 may be attached to the earplug 14without any treatment fluid 12 in the delivery bulb 16. In this case,delivery bulb 16 includes a pre-fill stem 88 with a distal end 90 and aone-way valve 92. Pre-fill stem 88 is a conduit fluidly connected to thedelivery bulb 16 so that treatment fluid 12 can pass into the pre-fillstem 88 at distal end 90 and travel through the pre-fill stem 88 to thedelivery bulb 16. Pre-fill stem 88 may be located anywhere on deliverybulb 16. In addition, pre-fill stem 88 may be made of the same materialas delivery bulb 16 and in fact may be molded with delivery bulb 16together with delivery bulb 16 as delivery bulb 16 is being molded.

One-way valve 92 is located either within pre-fill stem 88 or at thepoint where pre-fill stem 88 attaches to the delivery bulb 16. One-wayvalve 92 allows fluid to flow only in a direction from the distal end 90of pre-fill stem 88 to the delivery bulb 16. As such, one-way valve 92can take many forms so long as fluid, such as treatment fluid 12, isallowed to pass through one-way valve 92 to, but not out of, thedelivery bulb 16. Examples of valves appropriate for one-way valve 92include, but are not limited to, slit valves, check valves includingswing valves (monocuspid, bicuspid, tricuspid), lift valves, ballvalves, tilting disk valves, dual plate (leaflet) valves, diaphragmvalves, flap valves and general valves including ball valves, butterflyvalves, check valves, diaphragm valves, gate valves, globe valves, plugvalves, duck bill valves and pinch valves. In one embodiment, one-wayvalve 92 may be made of the same material as either the delivery bulb 16or prefill stem 88 or both and may be molded together with either thedelivery bulb 16, pre-fill stem 88 or both as the delivery bulb 16 orpre-fill stem 88 are molded.

In this embodiment, to fill delivery bulb 16, treatment fluid 12 isadded to the delivery bulb 16 by compressing the delivery bulb 16 toexpel air out of the delivery bulb 16 through lumen 24 past one-wayvalve 64. Then, while the delivery bulb 16 is still compressed, thedistal end 90 of pre-fill stem 88 is placed in a container of treatmentfluid 12. Thereafter, delivery bulb 16 is released where the material ofdelivery bulb 16 causes it to return to its uncompressed condition. Asdelivery bulb 16 returns to its uncompressed condition, it draws avacuum that sucks the treatment fluid 12 through the pre-fill stem 88past the one-way valve 92 into the delivery bulb 16.

In a slight variant of this embodiment shown in FIG. 16, the distal end90 of the pre-fill stem 88 has a luer connector 94 that may be mated toanother luer connector on, for example, a bag of treatment fluid 12 or asyringe filled with treatment fluid 12. In this way, treatment fluid 12can be transferred from a gross storage container into the delivery bulb16 to be delivered to the patient as described herein.

In another embodiment of the invention shown in FIG. 17, the deliverybulb 16 has a one-way valve 96 located at its distal end 38 near theconnection point to the earplug 14. One-way valve 96 is preferably avalve of the type that opens under pressure but remains closedotherwise. In this way, one-way valve 96 allows treatment fluid 12 topass out of the delivery bulb 16 when the delivery bulb 16 is squeezedto send the treatment fluid to the earplug 14 but prevents any treatmentfluid 12 remaining in the delivery bulb 16 from escaping from thedelivery bulb 16 when the delivery bulb 16 is separated from the earplug14. Examples of one-way valve 96 include, but are not limited to, slitvalves, check valves including swing valves (monocuspid, bicuspid,tricuspid), lift valves, ball valves, tilting disk valves, dual plate(leaflet) valves, double check valves, diaphragm valves, flap valves andgeneral valves including ball valves, butterfly valves, check valves,diaphragm valves, gate valves, globe valves, plug valves, foot valves,duck bill valves and pinch valves. It is clear that many valve types maybe used as one-way valve 96 including some not listed here. It isintended that any one-way valve that will occur to those skilled in theart that prevents treatment fluid 12 from escaping from the deliverybulb 16 when the delivery bulb 16 is separated from the earplug 14 maybe used for one-way valve 96.

Further, this configuration allows, but does not require, that theone-way valve 64 in the lumen 24 of earplug 14 may be eliminated andreplaced with a cap 98 attachable by frictional fit, mechanicalconnection or threads to the proximal end 30 of lumen 24. The functionof cap 98 is to close the proximal end 30 of lumen 24 once the treatmentfluid 12 has been delivered to the patient's external ear canal 26 andthe delivery bulb 16 separated from the earplug 14. Except as describedabove, in all other ways, the device 10 in the embodiment, including allthe embodiments and variations associated with the earplug 14 are asdescribed above. Specifically, this embodiment of the delivery bulb 16may be used with any embodiment of the device 10 above includingembodiments with one-way valve 64 in lumen 30.

It is also intended that the device 10, in an embodiment shown in FIG.18, be used with a syringe 100 such as is common in doctors' offices. Inthis embodiment, the distal end 102 of the syringe 100 is mated to theproximal end 20 of earplug 14. To accomplish this, the distal end 102 ofthe syringe 100 may be a common luer connection with the proximal end 20of earplug 14 formed as the corresponding luer connection. Alternately,the material of the proximal end 20 of earplug 14 may be extended toform an opening into which the distal end 102 of the syringe 100 maysecurely and sealingly fit in a male-female relationship. Other meansfor securing the distal end 102 of the syringe 100 to the proximal end20 of the earplug 14 will occur to those skilled in the art. Any suchmeans are intended to be included in the design of the device 10 in thisembodiment so long as the distal end 102 of the syringe 100 is securely,fluidly and sealingly mated to the proximal end 20 of the earplug 14. Inthis way, the syringe 100 can be filled with treatment fluid 12 as iscommon for such syringes or pre-filled with treatment fluid 12, as forexample by a third party and supplied as such, and stored for later use.

In either variant, when it is desired to use the device 10 and thereforesupply treatment fluid 12 to the device 10, the syringe 100 is connectedto the earplug 14 as described. Thereafter, the plunger mechanism on thesyringe 100 is activated to move treatment fluid 12 from the syringe 100to the earplug 14 to exit the earplug 14 at the orifice 34 as describedabove.

It is also intended in another embodiment of the device 10 shown in FIG.18, that the device 10 be used with an ear dropper 104 such as is commonin doctors' offices and at homes. In this embodiment, the distal end 106of the ear dropper 104 is mated to the proximal end 20 of earplug 14. Toaccomplish this, the distal end 106 of the ear dropper 104 may bechanged to form a common luer connection and the proximal end 20 ofearplug 14 is formed with the corresponding luer connection.Alternately, the material of the proximal end 20 of earplug 14 may beextended to form an opening into which the distal end 106 of the commonear dropper 104 may securely, sealingly and frictionally fit in amale-female relationship. Other means for securing the distal end 106 ofthe ear dropper 104 to the proximal end 20 of the earplug 14 will occurto those skilled in the art. Any such means are intended to be includedin the design of the device 10 in this embodiment so long as the distalend 106 of the ear dropper 104 is securely, fluidly and sealingly matedto the proximal end 20 of the earplug 14. In this way, the ear dropper104 can be filled with treatment fluid 12 as is common for such eardroppers or pre-filled with treatment fluid 12, as for example by athird party and supplied as such, and stored for later use.

In either variant, when it is desired to use the device 10 and thereforesupply treatment fluid 12 to the device 10, the ear dropper 104 isconnected to the earplug 14 as described. Thereafter, the bulb of theear dropper 104 is squeezed to move treatment fluid 12 from the eardropper 104 to the earplug 14 to exit the earplug 14 at the orifice 34as described above.

In all the embodiments shown above, a delivery bulb 16 holds thetherapeutic treatment fluid 12 for delivery to the earplug 14. In anembodiment shown schematically in FIG. 19, the treatment fluid 12 isstored in a reservoir 108 that is connected to a pump 110 that is inturn connected to the earplug 14 through a tube 112 that fluidlyconnects the pump 110 to the lumen 24. Pump 110 moves the treatmentfluid 12 from the reservoir 108 through tube 112 and lumen 24 to theorifice 34 where the treatment fluid 12 exits the earplug 14 asdescribed above. In this embodiment as well, a one-way valve 64 is againpreferably placed within the lumen 24 in earplug 14 to prevent treatmentfluid 12 from escaping the lumen 24 when the tube 112 is disconnectedfrom either the earplug 14. As a result, earplug 14 may receivetreatment fluid 12 from the reservoir 108 but allow the earplug 14 to beseparated from the reservoir 108 and pump 110 preferably at theconnection between the earplug 14 and the tube 112.

However, an additional one-way valve 114 may also be placed along tube112, preferably near where the tube 112 connects to the earplug 14, toprevent spillage of treatment fluid 12 from tube 112 when tube 112 isseparated from the earplug 14. Further, a one-way valve 116 may beplaced within tube 112 near where tube 112 connects to the pump 110 toprevent spillage of treatment fluid 12 out of the tube 112 if tube 112is separated from the pump 110. Another one-way valve or control valve110 may be placed in pump 110 near where pump 110 connects to the tube112 so that treatment fluid 12 will not spill from the pump 110 shouldthe tube 112 be disconnected from the pump 110. It is clear in thisembodiment that one-way valves 106, 108 and 110 may be used individuallyor in any combination. Further, one-way valves 106, 108 and 110 may beof the same type or of different types. In addition, the one-way valves106, 108 and 110 may be of different sizes, shapes, flow rates, openingpressures or other physical or functional properties.

FIG. 20 shows a slight variant of the device 10 of FIG. 19. In thisvariant, a pressure sensor 120 is placed in contact with tube 112 orpump 110 to sense the pressure provided by the tube 112 to the earplug14. Pressure sensor 120 is connected to a control circuit 114 that maybe a microprocessor, application specific integrated circuit (ASIC) ordiscrete components that respond to the pressure sensed by the pressuresensor 120 to produce a control signal for operating the pump 110. Ifthe pressure is too high, pump 110 is directed by control circuit 114 toadjust itself to reduce the pressure. Conversely, if the pressure is toolow, control circuit 114 directs the pump 110 to adjust itself toincrease the pressure.

In the embodiments of both FIGS. 18 and 19, the device 10 includes anearplug 14 in all the various embodiments described including with orwithout collection reservoir 68.

The device 10 described above in all its various embodiments andvariants may be applied to a multitude of ear care or therapeutic tasks.For example, the device 10 may be used for earwax irrigation, to delivertreatment fluids 12 to the patient's external ear canal 26 for atherapeutic benefit or to cleanse the external ear canal 26, or todeliver treatment fluids 12 to the middle ear through a tympanostomy orear drum perforation such as in the case of a middle ear infection(otitis media) or to dispense ear pain relieving fluid solutions (as inthe case of external ear canal inflammation as well as in a middle earinfection).

In any of these situations the delivery bulb 16 may be preloaded withthe specific treatment fluid 12 or it can be refilled for eachparticular use. In the embodiments where the delivery bulb 16 ispreloaded with treatment fluid 12, the delivery bulb 16 is manufacturedseparately or separated from the earplug 14, the delivery bulb 16 isfilled with the desired treatment fluid 12 and the delivery bulb 16re-attached to the earplug 14 with the delivery bulb 16 filled asdescribed above. Thereafter, the distal end 18 of the earplug 14 isplaced in the patient's external ear canal 26 until the outer body 22 ofthe earplug 14 forms a sealing fit with the patient's external ear canal26. When a seal is formed between the earplug 14 and the patient'sexternal ear canal 26, the delivery bulb 16 is squeezed whereby thetreatment fluid 12 is forced past the one-way valve 64, through thelumen 24 and out of the orifice 34 into the space in the patient'sexternal ear canal 26 between the distal end 46 of the earplug 14 andthe patient's eardrum 8. It may be desirable to place a pressure-reliefvalve on the delivery bulb 16 or along the lumen 24 or both to preventthe inadvertent application of too high of a pressure of the treatmentfluid 12 to the patient's external ear canal 26 or eardrum 8.

The one-way valve 64 prevents the treatment fluid 12 from leaving thearea distal to the distal end 18 of the earplug 14 and reentering thedelivery bulb 16 through the earplug 14. Further, in the embodimentswhere the delivery bulb 16 is removed from the earplug 14, the deliverybulb 16 may be removed from the earplug 14 so that the one-way valve 64forms a closure that keeps the treatment fluid 12 in the earplug 14 andthe patients external ear canal 26 in contact with the patient's middleear 26 and eardrum 8 for a therapeutically useful time period.

When it is desirable to remove the treatment fluid 12 from the patient'sexternal ear canal 26, in the embodiment where there is a collectionreservoir 68, the user releases or removes the pinch valve 86 if presentand collapses the collection reservoir 68 to draw a vacuum to draw thewaste treatment fluid 72 out of the patient's external ear canal 26 orjust lets the waste treatment fluid 72 drain into the collectionreservoir 68. Again, it may be desirable to include a pressure reliefvalve along the collection tube 66 or at the collection reservoir 68 orboth to prevent drawing too high a vacuum with the possible concomitantresult of damaging the patient's external ear canal 26 or eardrum 8.

In the embodiment where there is no collection reservoir 68, the earplug14 is removed from sealing contact with the patient's external ear canal26 whereupon the now waste treatment fluid 72 drains from the patient'sexternal ear canal 26 to be removed by, for example, a towel.

A part of the invention is to use the device 10 to treat treatingmaladies of the external ear canal 26 and eardrum 8 including bysupplying treatment fluids 12 to the external ear canal 26 and to andthrough the eardrum 8 where a tympanostomy tube is present.Consequently, methods for treating such maladies are disclosed. Examplesof specific maladies that can be treated with the device 10 describedherein are disclosed. However, these examples are intended to beillustrative and not limiting. It is clear that the device 10 disclosedcan be used to deliver treatment fluids 12 as described herein for manytherapies as will be clear to those skilled in the art.

To treat otalgia, otitis media, otitis externa, post tympanostomy tubeotorrhea and otorrhea with tympanic membrane perforation, in theembodiments using a delivery bulb 16, the delivery bulb 16 is eitherpreloaded with the specific treatment fluid 12 of choice (e.g., water,antibiotics, anti-inflammatory agents, or dehydrating solution) or, inthe embodiments described that allow the treatment fluid 12 to be drawninto the delivery bulb 16, the specific treatment fluid 12 of choice isdrawn into the delivery bulb 16. In the embodiments using a reservoir108, the specific treatment fluid 12 of choice is placed in thereservoir 108.

In any case, the earplug 14 is placed into the patient's external earcanal 26 so that the portions of the outer body 22 nearer the proximalend 20 of the earplug 14 comes into sealing contact with the patient'sexternal ear canal 26. Because body 22 is somewhat pliable, it willconform to the shape of the patient's external ear canal 26 as theearplug 14 is placed in the patient's external ear canal 26.

In the embodiments using a delivery bulb 16, the delivery bulb 16 issqueezed to send the treatment fluid 12 to the earplug 14 throughone-way valve 96 and lumen 24 to exit the device 10 through orifice 34where the treatment fluid 12 comes into therapeutic contact with thetissue of the external ear canal 26 or eardrum 8. The sealing contactbetween the body 22 and the patient's external ear canal 26 retains thetreatment fluid 12 in this therapeutic contact with the tissue. In theembodiments using a reservoir 108, the pump 110 is activated to send thetreatment fluid to and through the earplug 14 and out the orifice 34.

In the embodiments having a collection tube 66 and a collectionreservoir 68, collection reservoir 68 is preferably compressed prior tothe user inserting the earplug 14 into the patient's external ear canal26 and the pinch valve 86 closed. In this way, a slight vacuum tendencyof the collection reservoir 68 as it attempts to return to itsuncompressed state is preserved. When the user desires to remove thewaste treatment fluid 72 from the patient's external ear canal 26, thepinch valve 86, if present, is opened and collection reservoir 68provides a slight vacuum as it rectums to its unstressed condition topull the waste treatment fluid 72 into the collection orifice 70,through the collection tube 66 (and through the hollow conduit 84, ifpresent) into the collection reservoir 68. The collection reservoir 68containing the waste treatment fluid 72 may then be discarded or thewaste treatment fluid 72 drained from the collection reservoir 68 anddiscarded.

To treat cerumen otic impaction, in the embodiments using a deliverybulb 16, the delivery bulb 16 is either preloaded with the specifictreatment fluid 12 of choice (e.g., water, hydrogen peroxide, mineraloil, baby oil, Burrow's solution, or any other biologically compatiblefluid that irrigates or moisturizes the external ear canal 26 or breaksdown or dissolves cerumen) or, in the embodiments described that allowthe treatment fluid 12 to be drawn into the delivery bulb 16, thespecific treatment fluid 12 of choice is drawn into the delivery bulb16. In the embodiments using a reservoir 108, the specific treatmentfluid 12 of choice is placed in the reservoir 108.

In any case, the earplug 14 is placed into the patient's external earcanal 26 so that the portions of the outer body 22 nearer the proximalend 20 of the earplug 14 comes into sealing contact with the patient'sexternal ear canal 26. Because body 22 is somewhat pliable, it willconform to the shape of the patient's external ear canal 26 as theearplug 14 is placed in the patient's external ear canal 26.

In the embodiments using a delivery bulb 16, the delivery bulb 16 issqueezed to send the treatment fluid 12 to the earplug 14 throughone-way valve 96 and lumen 24 to exit the device 10 through orifice 34.It may be desirable to direct the treatment fluid 12 onto areas in thepatient's external ear canal 26 where the cerumen is located to use thephysical contact between the treatment fluid 12 and the cerumen to helpdislodge the cerumen. In this case, it may be desirable to use anearplug 14 with an orifice 34 located along the surface of the outerbody 22 away from the ultimate distal end 18 of earplug 14 but stillbefore the part of outer body 22 that contacts and provides a seal withthe patient's external ear canal 26 (FIG. 4). The sealing contactbetween the body 22 and the patient's external ear canal 26 retains thetreatment fluid 12 in this therapeutic contact with the tissue. In theembodiments using a reservoir 108, the pump 110 is activated to send thetreatment fluid to and through the earplug 14 and out the orifice 34.

In the embodiments having a collection tube 66 and a collectionreservoir 68, collection reservoir 68 is preferably compressed prior tothe user inserting the earplug 14 into the patient's external ear canal26 and the pinch valve 86 closed. In this way, a slight vacuum tendencyof the collection reservoir 68 as it attempts to return to itsuncompressed state is preserved. When the user desires to remove thewaste treatment fluid 72 from the patient's external ear canal 26, thepinch valve 86, if present, is opened and collection reservoir 68provides a slight vacuum as it returns to its unstressed condition topull the waste treatment fluid 72 into the collection orifice 70,through the collection tube 66 (and through the hollow conduit 84, ifpresent) into the collection reservoir 68. The collection reservoir 68containing the waste treatment fluid 72 may then be discarded or thewaste treatment fluid 72 drained from the collection reservoir 68 anddiscarded.

The present invention has been described in connection with certainembodiments and dimensions. It is to be understood, however, that thedescription given herein has been given for the purpose of explainingand illustrating the invention and are not intended to limit the scopeof the invention. For example, as is well understood in the art, it isclear that a near infinite number of manners of connecting the deliverybulb 16 to the earplug 14 or each of these to tube 32 may be used. It isnot intended that the invention be limited to the specific designsshown. Rather, the invention is intended to encompass the elementsdisclosed and their functional equivalents interacting as describedherein.

Further, the present invention has been described in connection withdevices and methods for treating maladies of the external ear canal,middle ear and eardrum and more particularly to such devices and methodsthat supply treatment fluids to the external ear canal and into themiddle ear through the eardrum where a tympanostomy tube or aperforation is present. However, it is within the scope of the inventionto provide devices 10, as described herein, for delivering treatmentfluid to other body orifices or cavities. For example, for the purposeof illustration and not by way of limitation, the following are a fewexamples of uses of the device 10 in other body cavities and orifices:

1. Rectal applications such as in enema flushes, hemorrhoid medicationinsertion and other types of solutions that are known by those skilledin the art to be applied into and through the anorectal area The device10 may also be used for the injection of contrast material into thecolon such as used in barium enemas.

2. Nasal irrigation and instillation of nasal solutions such asantibiotics, antifungals, decongestants and other solutions known bythose skilled in the art to be administered to the nose, nasal passagesor sinuses.

3. Urologic applications including the injection of urinary irrigationsolutions, contrast dye, antibiotics and other medications known bythose skilled in the art that are delivered into the urethra. In all ofthe above listed applications of the device 10, a common goal is thedelivery of a therapeutic solution into a body orifice or cavity withthe advantage of the device 10, as described in this specification, inpreventing solution backflow, enabling an individual to be ambulatoryand collecting of the used solution into a reservoir. Consequently, thedevice 10 in these and similar applications is substantially asdescribed above with the exception that the earplug 14 is modified insize, shape and possibly other physical properties such as flexibility,rigidity and pliancy to become a plug 14′ that accommodates forming asealing fit with the orifice or body cavity to which it is applied.

The device 10 according to this embodiment of the invention is used totreat maladies of a patient's body orifice or body cavity by deliveringa therapeutic solution into a body orifice or body cavity. This would beaccomplished by providing a treatment fluid delivery device 10comprising a delivery bulb 16 capable of holding a treatment fluid 12; aplug 14′ removably connectable to the delivery bulb 16, the plug 14′having a distal end 18, a proximal end 20, an outer body 22 having anouter surface and a lumen 24 having a distal end 28 and a proximal end30 wherein the lumen 24 terminates in an orifice 34 at the distal end 28of the lumen 24, the proximal end 30 of the lumen 24 fluidly connectedto the delivery bulb 16 so that treatment fluid 12 in the delivery bulb16 may pass from the delivery bulb 16 to exit the plug 14′ through theorifice 34, the plug 14′ having a one-way valve 64 to prevent treatmentfluid 12 from re-entering the delivery bulb 16 once treatment fluid 12has left the delivery bulb 16, wherein the delivery bulb 16 may beremoved from the plug 14′ when the plug 14′ is in position in apatient's body orifice or body cavity. Thereafter, a specific treatmentfluid 12 of choice is placed into the delivery bulb 16. Then, the plug14′ is placed into a patient's body orifice or body cavity so that theportions of the outer body 22 nearer the proximal end 20 of the plug 14′come into sealing contact with the patient's body orifice or bodycavity. The delivery bulb 16 is then squeezed to send the treatmentfluid 12 to the plug 14′ through the one-way valve 64 and the lumen 24to exit the device 10 through the orifice 34 where the treatment fluid12 comes into therapeutic contact with the tissue of the patient's bodyorifice or body cavity.

In a variant of this embodiment, the device 10 is used to treat maladiesof a patient's body orifice or body cavity by delivering a therapeuticsolution into a body orifice or body cavity by providing a treatmentfluid delivery device comprising a reservoir 108 capable of holding atreatment fluid 12; a plug 14′ removably connectable to the reservoir108, the plug 14′ having a distal end 18, a proximal end 20, an outerbody 22 having an outer surface and a lumen 24 having a distal end 28and a proximal end 30 wherein the lumen 24 terminates in an orifice 34at the distal end 28 of the lumen 24, the proximal end 30 of the lumen24 fluidly connected to the reservoir 108 so that treatment fluid 12 inthe reservoir 108 may pass from the reservoir 108 to exit the plug 14′through the orifice 34, the plug 14′ having a one-way valve 64 toprevent treatment fluid 12 from re-entering the reservoir 108 oncetreatment fluid 12 has left the reservoir 108, wherein the reservoir 108may be removed from the plug 14′ when the plug 14′ is in position in apatient's body orifice or body cavity; and a pump 110 fluidly connectedbetween the plug 14′ and the reservoir 108 to move treatment fluid 12from the reservoir 108 through the lumen 24 to the orifice 34 where thetreatment fluid 12 exits the plug 14′. Thereafter, a specific treatmentfluid 12 of choice is placed into the reservoir 108. Then, the plug 14′is placed into a patient's body orifice or body cavity so that theportions of the outer body 22 nearer the proximal end 20 of the plug 14′comes into sealing contact with the patient's body orifice or bodycavity. The pump is then activated to send the treatment fluid 12 to theplug 14′ through the one-way valve 64 and the lumen 24 to exit thedevice 10 through the orifice 34 where the treatment fluid 12 comes intotherapeutic contact with the tissue of the patient's body orifice orbody cavity.

In either method to treat maladies of a patient's body orifice or bodycavity described above, the method further comprises providing acollection orifice 70, located near the distal end 18 of the plug 14′; acollection reservoir 68; and a collection tube 66 connecting thecollection reservoir 68 to the collection orifice 70, all substantiallyas described in this specification. In an alternate example embodiment,depicted in FIG. 21, the treatment delivery device 124 includes an earcanal engaging portion 126 integrally formed with an external portion130, and defines an internal lumen 132 that extends through both. Theear canal engaging portion 126 is composed of a soft, molded, resilientmaterial such as silicone, polyurethane, or another FDA-approvedbiocompatible material. Ear canal engaging portion 126 is dimensioned sothat the distal end 128 may be placed into the external ear canal 26 ofthe patient. Moving proximally toward the external portion 130, the earcanal engaging portion 126 gradually increases in diameter until itmerges with the external portion 130.

Spaced approximately equally along the length of the ear canal engagingportion 126 are minor disks 134, 136, and 138. The most distal minordisk 134 is located at or near the most distal end 128 of ear canalengaging portion 126. Minor disk 134 includes a proximal concave surface142 and a distal convex surface 144. Proximal concave surface 142 isjoined to distal convex surface 144 by a ridge 146.

Further proximally, ear canal engaging portion 126 presents a secondminor disk 136. Minor disk 136 includes a proximal concave surface 148and a distal convex surface 150. Proximal concave surface 148 is joinedto distal convex surface 150 by a ridge 152. Additionally, minor disk136 is slightly larger in diameter than minor disk 134.

Still further proximally, ear canal engaging portion 126 presents athird minor disk 138. Minor disk 138 includes a proximal concave surface154 and a distal convex surface 156. Proximal concave surface 154 isjoined to distal convex surface 156 by a ridge 158. Minor disk 138 isslightly larger in diameter than minor disk 136. Additionally, in anexample embodiment, the distance between minor disk 134 and minor disk136 is approximately equal to the distance between minor disk 136 andminor disk 138.

The proximal end of ear canal engaging portion 126 merges with externalportion 130 of the treatment delivery device 124 to form one, unitarydevice. The external portion 130 includes major disk 140, an annularmedication applicator receiving portion 160, and defines an internallumen 132. The major disk 140 presents a proximal concave surface 162and a distal convex surface 164. The proximal concave surface 162 andthe distal convex surface 164 are joined by an intermediate member 166.Intermediate member 166 is a flat surface in this example. The majordisk 140 is laterally offset from the internal lumen 132. The internallumen 132 is joined to major disk 140 by the annular medicationapplicator receiving portion 160. The annular medication applicatorreceiving portion 160 is also formed of a soft, molded, resilientmaterial such as silicone, polyurethane, or some other FDA-approvedbiocompatible material along with the rest of treatment delivery device124. The annular medication applicator receiving portion 160 presents anannular ring 168, a first annular wall 164, and a second annular wall166. The annular ring 168 has a flat surface. The proximal concavesurface 162 is joined to the first annular wall 164 by a fillet 169. Theinternal lumen 132 is in fluid communication with the ear canal engagingportion 126.

Referring to FIG. 22, the wall of internal lumen 132 presents a firstsegment 172, a second segment 174, and a third segment 176 whencross-sectioned. The first segment 172 is located generally within minordisk 134 and has a generally frustoconical contoured shape.

Further proximally, the second segment 174 extends approximately betweenminor disk 134 and minor disk 136 and has a generally cylindrical shape.The second segment 174 presents a valve structure 178. The valvestructure 178 includes a first leaflet 180 and a second leaflet 182.Each of leaflets 180 and 182 is shaped as half of a hemicylinders inthis example embodiment. The planar surfaces along the longitudinal axesof leaflet 180 and leaflet 182 abut to form the valve structure 176. Theleaflets 180 and 182 forming the valve structure 178 are made of anintegrally molded, resilient material, consistent with that of thesurrounding ear canal engaging portion 126. The resilient materialallows the valve structure 178 to open in either direction under apreselected fluid pressure and close below the preselected fluidpressure, as depicted in FIGS. 23 and 24. The resilient material alsoallows for long-term therapeutic benefit by retaining the fluid in thetreatment delivery device 124 for a desired period of time.

Still further proximally, the third segment 176 of internal lumen 132begins at approximately the midpoint of minor disk 136 and continuesthrough the annular medication applicator receiving portion 160. Thethird segment 176 also has walls defining a generally frustoconicalshape. Third segment 176 has a chamfered edge 184 where it merges withsecond segment 174. At the proximal end of third segment 174 there is anannular indent 186 where it merges with the second annular wall 166.Although third segment 176 is generally frustoconical in shape it mayalso have a convex curvature 188 as depicted in FIG. 22.

Referring to FIG. 25, the treatment delivery device 124 is depicted inthe external ear canal 26 of a patient. Also depicted is the eardrum 8of the patient's ear (not to scale). The minor disks 134, 136, and 138of treatment delivery device 124 are dimensioned such that they form aresilient seal with the wall of the external ear canal 26.

Referring to FIG. 26, the treatment delivery device 124 is depicted inthe external ear canal 26 of the patient. Also depicted is the eardrum 8of the patient's ear (not to scale). The minor disks 134, 136, and 138of treatment delivery device 124 are dimensioned such that they form aresilient seal with the wall of the external ear canal 26. A medicationapplicator tip 190 is also shown within the treatment delivery device124. The medication applicator tip 190 is designed such that it isseated within the contours of internal lumen 132 to form a seal. Themedication applicator tip 190 is adjacent to molded, resilient valve180.

Referring to FIG. 27, the treatment delivery device 124 is shown in theexternal ear canal 26 of the patient. The minor disks 134, 136, and 138of treatment delivery device 124 are dimensioned such that they form aseal with the wall of the external ear canal 26. The medicationapplicator tip 190 is also shown within the treatment delivery device124. The medication applicator tip 190 is designed such that it isseated within the contours of internal lumen 132 to form a seal. Theminor disks 134, 136, and 138 are resilient to a degree such that underair pressure of air displaced by the entrance of fluid through molded,resilient valve 178 minor disks 134, 136, and 138 “give” to permit theescape of displaced air 194 as depicted by small arrows. The medicationapplicator tip 190 is adjacent to molded, resilient valve 178. Themolded, resilient valve 178 opens in either direction under apreselected fluid pressure and closes below the preselected fluidpressure. A treatment fluid 192 is depicted exiting the molded,resilient valve 178 after the preselected fluid pressure has beenreached. As the treatment fluid 192 departs the treatment deliverydevice 124, air 194 escapes between external ear canal 26 and treatmentdelivery device 124.

In operation, a healthcare provider inserts the treatment deliverydevice 124 into the external ear canal 26 of a patient, as depicted inFIG. 25. The treatment delivery device 124 is made with a molded,resilient material such as silicone, polyurethane, or some otherFDA-approved biocompatible material and gives resiliently to conform toexternal ear canal 26. The minor disks 134, 136, and 138 of the earcanal engaging portion 126 of the treatment delivery device 124 aredimensioned such that they form a seal with the wall of the external earcanal 26, as depicted in FIG. 26. The major disk 140 of the treatmentdelivery device 124 sits along the outer edge of external ear canal 26,and affords the healthcare provider access to the internal lumen 132 ofthe treatment delivery device 124.

In one embodiment of the invention, the healthcare provider inserts themedication applicator tip 190 of a syringe, ear dropper, eye dropper, orsimilar applicator filled with treatment fluid 192 into the treatmentdelivery device 124. The healthcare provider then inserts deliverydevice 124 assembled to medication applicator tip 190 into the externalear canal 26. The medication applicator tip 190 is generally prefilledwith treatment fluid 192 prior to assembly with delivery device 124.

The resiliency of the treatment delivery device 124 allows thehealthcare provider to stretch the annular medication applicatorreceiving portion 160 to accommodate medication applicator tip 190, anddelivery the treatment fluid 192.

Referring to FIG. 27, the treatment fluid 192 is then delivered into theinternal lumen 132 of the treatment delivery device 124. Once thetreatment fluid 192 reaches a certain preselected pressure, the valvestructure 178 opens and the treatment fluid 192 exits the treatmentdelivery device 124 and flows into the external ear canal 26 andcontacts external ear canal 26 and eardrum 8. Air 194 is displaced whenthe treatment fluid 192 flows into the external ear canal 26, andescapes between the treatment delivery device 126 and the walls ofexternal ear canal 26. Alternatively, treatment delivery device 124 canbe kept in place within the external ear canal 26, with the treatmentfluid 192 inside and retained in contact with eardrum 8 and external earcanal 26 structures for a period of time for long-term therapeuticbenefit.

It is to be further understood that changes and modifications to thedescriptions given herein will occur to those skilled in the art.Therefore, the scope of the invention should be limited only by thescope of the following claims.

1. An ear medication delivery device for delivering a treatment liquidand retaining the treatment liquid within an ear canal of a patient,comprising: a unitary, one piece earplug formed of a soft resilientmaterial including an ear canal engaging portion and an external portionand defining a single internal passage extending from a first end of theearplug to a second end of the earplug therethrough; the externalportion including a major disk and an annular medication applicatorreceiving portion in fluid communication with the internal passage; theear canal engaging portion including at least two minor disks ofprogressively different size extending outwardly therefrom in agenerally radial direction; the ear canal engaging portion defining amolded resilient valve unitary with the earplug that is shiftable from aclosed position to an open position in either direction under apreselected fluid pressure and that resiliently returns to the closedposition below the preselected fluid pressure.
 2. The ear medicationdelivery device as claimed in claim 1, further comprising a unitaryannular gasket extending inwardly at an interior rim of the annularmedication applicator.
 3. The ear medication delivery device as claimedin claim 1, wherein the molded resilient valve is located proximate adistal end of the canal engaging portion and presents a generallyfrustoconical tapered entrance facing proximally.
 4. The ear medicationdelivery device as claimed in claim 1, wherein the molded resilientvalve is located proximate a distal end of the canal engaging portionand presents a generally frustoconical exit facing distally.
 5. The earmedication delivery device as claimed in claim 1, wherein the major diskis curved convexly on a distal side thereof and concavely on a proximalside thereof.
 6. The ear medication delivery device as claimed in claim1, wherein at least one of the minor disks is curved convexly on adistal side thereof and concavely on a proximal side thereof.
 7. The earmedication delivery device as claimed in claim 1, wherein the minordisks taper from smallest at a distal end of the ear canal engagingportion.
 8. The ear medication delivery device as claimed in claim 1,wherein and exterior of the ear canal engaging portion tapers fromsmaller near a distal end thereof to larger near the major disk.
 9. Theear medication delivery device as claimed in claim 1, wherein the majordisk is offset laterally relative to the ear canal engaging portion. 10.The ear medication delivery device as claimed in claim 1, wherein themolded resilient valve further comprise a first leaflet and a secondleaflet.
 11. The ear medication delivery device as claimed in claim 10,wherein at least one of the first leaflet and the second leafletcomprises a generally hemicylindrical structure.
 12. The ear medicationdelivery device as claimed in claim 10, wherein each of the firstleaflet and the second leaflet further comprise a generally planarinternally facing surface, the internally facing surface of the firstleaflet and the internally facing surface of the second leaflet beinggenerally opposed and positioned in abutting relation to each other. 13.The ear medication delivery device as claimed in claim 10, wherein thefirst leaflet and the second leaflet abut in sealing opposition topresent a slit shaped potential opening therebetween.
 14. The earmedication delivery device as claimed in claim 1, wherein the annularmedication applicator receiving portion is shaped to complement atapered end of a conventional ear dropper to receive the tapered end ofthe conventional ear dropper in close sealing relation.
 15. A method oftreating ear maladies, comprising: inserting a unitary, one pieceearplug formed of a soft resilient material including an ear canalengaging portion and defining a single internal passage extending from afirst end of the earplug to a second end of the earplug therethroughinto an ear canal of a patient so that at least one minor disk of theear canal engaging portion engages a wall of the ear canal; injecting aliquid treatment medication through the single internal passage into theear canal; and selecting the unitary, one piece earplug to beappropriately flexible to permit air in the ear canal that is displacedby the liquid treatment medication to escape between the at least oneminor disk and the wall of the ear canal.
 16. The method as claimed inclaim 15, further comprising engaging a tapered end of an ear dropperinto an annular medication applicator receiving portion of the unitary,one piece earplug.
 17. The method as claimed in claim 15, furthercomprising selecting the unitary, one piece earplug to include a moldedresilient valve unitary with the earplug that is shiftable from a closedposition to an open position in either direction under a preselectedfluid pressure and that resiliently returns to the closed position belowthe preselected fluid pressure.